It's a fake.......

1. At
Submitted By
ANURAG RANJAN
Submitted To
Department of Pharmacy
"ESTEEM INDUSTRIES
INC; BADDI(HP)
GURU NANAK INSTITUTE OF TECHNOLOGY
(AMBALA)
PHARMACY SCHOOL REPORT OF INDUSTRIAL TRAINING

2. ACKNOWLEDGMENT
• It is a matter of pleasure and happiness to make and submit this industrial
training report during course of the completion of this industrial work.
• Many of the person have offered their valuable and enormous support.
• I am thankful to all my teacher of Guru Nanak institute of
Technology , Mullana. For their blessing and encouragement.
• I would like to express my special thanks and gratitude to CASACA
Remedies PVT.LTD (Ambala Cantt) providing all the essential facilities
which were required for this training.
• Finally, I express my regards to my beloved parent who inspired
me throughout my studies and completion of this training.
4th year B.Pharma
(7th – Sem)
Anurag ranjan jha

3. OBJECTIVE OF INDUSTRIAL TRAINING
• The purpose of Industrial Training is to expose student to real work of environment
experience and at the same time, to gain the knowledge through hand on observation and
job execution. From the industrial training , the will also develop skills in work ethics,
communication, management and other. Moreover, this practical training program allows
student to relate theoretical knowledge with its application in the manufacturing
industry.
The objective of industrial training are:
. To provide student the opportunity to test interest in a particular career before permanent
commitment are made.
. To develop skill in the application of theory to practical work situation .
. To develop skill and techniques directly application to their careers.
. Internship will increase a students sense of responsibility and good work habits.
. Internship student will have higher level of academic performance.
. To build the strength teamwork spirit and self-confidence in student life.
. To enhance the ability to improve student creativity skill and sharing idea.
. The student will be able to instilled with good moral values such as responsibility,
commitment and trustworthy during their training.

4. PHARMACEUTICAL COMPANY
• MISSON
To manufacture a range of benchmark quality product to address a spectrum of medical
needs . To provide these quality product at highly competitive prices, reach maximum
number of end users in India. Which leads to our customers delight
VISION
To be recognized as leaders in India and global market manufacturing advanced
technology intravenous infusion and other healthcare product.
QUALITY
To manufacture and supply quality product timely by continuous improvement, thereby
making our product easily accessible at competitive prices for the welfare of mankind.
STORE
STORE IS IMPORTANT TO ENSURE.
1. To raw material should be supply at right time in the store
2. To avoid wastage and shortage and maintain optimal stock
3. Reduce investment

5. SAMPLEING AREA
• Raw Material Handling System:
(A) Receipt of Material
All incoming material must be visually examined
Following thing must be checked and Recorded:
(1) Control number assigned by manufacturer; with the name of the product and batch number.
(2) Quantity received against the document.
(3) Name of supplier/ manufacturer.
(4) Purchase order number.
(B) Storage of Material:
Following point should be covered:
(1) External cleaning of the container after receiving and before storage.
(2) Quantity verification.
(3) Storage in the specified area as per the storage condition.
(4) Storage as per quarantined status of the material.
Handling of Waste Material:
Pharmaceutical manufacturing operation generates lot of the waste material. These material
can be classified mainly in two categories:
1) Trash: Which do not have any release value and may be disposed of by proper method depending
upon the nature of the trash.
2)Scrap: Which do not have any resale value and may be sold to the scarp dealers.
After proper segregation. Toxic substance and flammable material should be stored in suitable stored
cupboard, as required in national legislation.

6. Quality control
• Quality control (QC) is a process by which entities review the quality of all factors involved
in production. ISO 9000 defines quality control as "a part of quality management focused on
fulfilling quality requirements".
• This approach places emphasis on three aspects (enshrined in standards such as ISO 9001):
• Elements such as controls, job management, defined and well managed processes,performance
and integrity criteria, and identification of records
• Competence, such as knowledge, skills, experience, and qualifications
• Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team
spirit, and quality relationships.
• KEY TAKEAWAYS
• Quality control (QC) is a process through which a business seeks to ensure that product quality is
maintained or improved.
• Quality control involves testing units and determining if they are within the specifications for the
final product.
• The quality control used in a business is highly dependent on the product or industry, and several
techniques exist for measuring quality.
• The food industry uses quality control methods to ensure customers do not get sick from their
products.
• Quality control creates safe measures that can be implemented to make sure deficient or damaged
products do not end up with customers.

7. QUALITY CONTROL TEST FOR TABLET:
• They are called official tests because the test methods are described in official
compendia such as the British Pharmacopoeia, American Pharmacopoeias etc.
They are standardized test procedures which have clearly stated limits under
which compressed tablets could be accepted. These tests include:
• Content of Active Ingredient/ Absolute drug content test
• Uniformity of Weight
• Uniformity of Content
• Disintegration time test
• Dissolution test
Uniformity of Weight/ Weight variation test
• The test for uniformity of weight is performed by weighing individually 20 tablets
randomly selected from a tablet batch and determining their individual weights.
The individual weights are compared with the average weight.
• The sample complies with USP standard if no more than 2 tablets are outside the
percentage limit and if no tablet differs by more than 2 times the percentage limit.
• Coated tablets are exempted from these requirements but must conform to the
test for content uniformity.

8. Quality Control and Evaluation Parameters for
Chewable Tablets
• Uniformity of Content
• Content uniformity test was developed to ensure content consistency of active drug substances
within a narrow range around the label claim in dosage units. This test is crucial for tablets having a
drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total
tablet weight.
• By the USP method, 30 tablets are randomly selected, 10 of these tablets are assayed individually
according to the method described in the individual monograph. Unless otherwise stated in the
monograph, the requirements for content uniformity are met if the amount of active ingredient in
nine (9) of the ten (10) tablets lies within the range of 85% to 115% of the label claim. The tenth
tablet may not contain less than 75% or more than 125% of the labelled drug content.
• If one or more dosage units do not meet these criteria, the remaining 20 tablets are assayed
• individually and none may fall outside of the 85% to 115% range for the batch to be accepted.
• Various factors are responsible for the variable content uniformity in tablets. This may include:
• Tablet weight variation.
• Uneven distribution of the drug in the powder or granules
• Segregation of the powder mixture or granulation during formulation processes
DISINTEGRATION TIME TEST

9. DISINTEGRATION TIME TEST

10. the first important step towards drug dissolution is breakdown of the tablets into
granules or primary powder particles, a process known as disintegration. All USP
tablets must pass a test for disintegration, which is conducted in vitro using a
disintegration test apparatus
• The apparatus consists of a basket-rack assembly containing six open-ended transparent tubes of USP-
specified dimensions, held vertically upon a 10-mesh stainless steel wire screen.
• During testing, a tablet is placed in each of the six tubes of the basket, and through the use of a
mechanical device, the basket is raised and lowered in a bath of fluid (e.g. water, or as prescribed in the
individual drug monograph) at 29 to 32 cycles per minute, the wire screen always below the level of the
fluid. For most normal release tablets, the time permitted is 15 minutes.
• Tablets are said to have disintegrated if no fragments (other than fragments of coating) remains on the
screen, or if particles remain, they are soft without An unwetted core. Chewable tablets are not required
to comply with the test. DISSOLUTION TEST APPARATUS:
• In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in
vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch
consistency of solid oral dosage forms such as tablets, and drug development, i.e., to
predict in vivo drug release profiles.[1] There are three typical situations where dissolution
testing plays a vital role: (i) formulation and optimization decisions: during product
development, for products where dissolution performance is a critical quality attribute, both
the product formulation and the manufacturing process are optimized based on achieving
specific dissolution targets. (ii) Equivalence decisions: during generic product development,
and also when implementing post-approval process or formulation changes, similarity of in
vitro dissolution profiles between the reference product and its generic or modified version
are one of the key requirements for regulatory approval decisions. (iii) Product compliance
and release decisions: during routine manufacturing, dissolution outcomes are very often
one of the criteria used to make product release decisions.
• The main objective of developing and evaluating an IVIVC is to establish the dissolution test
as a surrogate for human studies, as stated by the Food and Drug
Administration (FDA).[5] Analytical data from drug dissolution testing are sufficient in many
cases to establish safety and efficacy of a drug product without in vivo tests, following minor
formulation and manufacturing changes. Thus, the dissolution testing which is conducted in
dissolution apparatus must be able to provide accurate and reproducible results.

11. Several dissolution apparatuses exist. In United States Pharmacopeia (USP) General Dissolution,
there are four dissolution apparatuses standardized and specified. They are:
USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C )
USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C)
USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
USP Dissolution Apparatus 4 – Flow-Through Cell (37 °C ± 0.5 °C)
USP Dissolution Apparatus 5 - Reciprocating Disk (37 °C ± 0.5 )

12. Friability test:

13. Friability test apparatus:
• Apparatus: The Tablet Friability apparatus is used for testing. This apparatus consists of a
drum of transparent synthetic polymer with polished internal surfaces and is subject to
minimum static build-up. One side of the drum is removable. It has a curved projection which
extends from the middle of the drum to the outer wall, enabling the tumbling of the tablets
at each turn of the drum. The drum is attached to the horizontal axis of a device. It rotates at
25 ± 1 rpm. The other specifications are as follows:
• Special Consideration:
• It should be ensured that with every turn of the drum the tablets roll or slide and fall onto
the drum wall or onto each other.
• The sample fails the test if obviously cracked, chipped or broken tablets are present in the
sample.
• Dedust tablets carefully prior to testing.
• If tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms
an angle of about 10° with the horizontal and the tablets no longer bind together when lying
next to each other, which prevents them from falling freely.
• Effervescent tablets and chewable tablets may have different specifications as far as friability
is concerned.
• Appropriate humidity-controlled environment shall be provided for testing of hygroscopic
tablets.
•

14. HARDNESS TEST:
• Tablet hardness testing is a laboratory technique used by
the pharmaceutical industry to determine the breaking point and structural
integrity of a tablet and find out how it changes "under conditions of storage,
transportation, packaging and handling before usage“
List of common hardness testers:
• The Monsanto tester was developed 50 years ago. The design consists of "a barrel
containing a compressible spring held between 2 plungers". The tablet is placed on
the lower plunger, and the upper plunger is lowered onto it.
• The Strong-Cobb tester forces an anvil against a stationary platform. Results are
viewed from a hydraulic gauge.The results are very similar to that of the Monsanto
tester.
• The Pfizer tester compresses tablet between a holding anvil and a piston
connected to a force-reading gauge when its plier-like handles are gripped.
• The Erweka tester tests a tablet placed on the lower anvil and a weight moving
along a rail transmits pressure slowly to the tablet.

15. UV VISIBLE SPECTROSCOPY
• Ultraviolet-visible spectroscopy or ultraviolet-visible spectrophotometry (UV-Vis or
UV/Vis) refers to absorption spectroscopy or reflectance spectroscopy in the ultraviolet-
visible spectral region. Ultraviolet-visible (UV-VIS) spectroscopy is an analytical method
that can measure the analyte quantity depending on the amount of light received by
the analyte.
• Ultraviolet/Visible area (UV-Vis) measurements span wavelengths from around 200 nm
to 800 nm. The absorption by a molecule of ultraviolet or visible radiation results in
transitions between the molecule’s electrical energy levels. The optical and electronic
properties of different materials, such as films, powders, monolithic solids, and liquids,
are suitable for characterization.
• UV-vis spectroscopy is a cost-effective, simple, versatile, non-destructive, analytical
technique suitable for a large spectrum of organic compounds and some inorganic
species. As a function of wavelength, UV-vis spectrophotometers measure the
absorption or transmission of light that passes through a medium.
• A common technique for quantitative analysis of analytes in QA/QC, analytical research,
and government regulatory laboratories is UV-Visible spectrophotometry. The
fundamentals of the approach are learned in school, such as Beer’s Law. UV-Visible
Mid-range to Upper-end Spectrophotometers are typically used in research
laboratories, including university and industrial laboratories.

16. IR SPCTROSCOPY
• Infrared spectroscopy (IR spectroscopy or vibrational spectroscopy) is the measurement of
the interaction of infrared radiation with matter by absorption, emission, or reflection. It is
used to study and identify chemical substances or functional groups in solid, liquid, or
gaseous forms. It can be used to characterize new materials or identify and verify known and
unknown samples. The method or technique of infrared spectroscopy is conducted with an
instrument called an infrared spectrometer (or spectrophotometer) which produces
an infrared spectrum. An IR spectrum can be visualized in a graph of infrared
light absorbance (or transmittance) on the vertical axis
vs. frequency, wavenumber or wavelength on the horizontal axis. Typical units of
wavenumber used in IR spectra are reciprocal centimeters, with the symbol cm−1. Units of IR
wavelength are commonly given in micrometers (formerly called "microns"), symbol μm,
which are related to the wavenumber in a reciprocal way. A common laboratory instrument
that uses this technique is a Fourier transform infrared (FTIR) spectrometer.
• The infrared spectrum of a sample is recorded by passing a beam of infrared light through the
sample. When the frequency of the IR is the same as the vibrational frequency of a bond or
collection of bonds, absorption occurs. Examination of the transmitted light reveals how
much energy was absorbed at each frequency (or wavelength). This measurement can be
achieved by scanning the wavelength range using a monochromator

17. HIGH PERFORMANCE LIQUID CHROMATOGRAPHY:
• High-performance liquid chromatography (HPLC), formerly referred to as high-pressure liquid
chromatography, is a technique in analytical chemistry used to separate, identify, and quantify each
component in a mixture. It relies on pumps to pass a pressurized liquid solvent containing the sample
mixture through a column filled with a solid adsorbent material. Each component in the sample interacts
slightly differently with the adsorbent material, causing different flow rates for the different components
and leading to the separation of the components as they flow out of the column.
• HPLC has been used for manufacturing (e.g., during the production process of pharmaceutical and
biological products), legal (e.g., detecting performance enhancement drugs in urine), research (e.g.,
separating the components of a complex biological sample, or of similar synthetic chemicals from each
other), and medical (e.g., detecting vitamin D levels in blood serum) purposes.
• Chromatography can be described as a mass transfer process involving adsorption. HPLC relies on pumps
to pass a pressurized liquid and a sample mixture through a column filled with adsorbent, leading to the
separation of the sample components. The active component of the column, the adsorbent, is typically a
granular material made of solid particles (e.g., silica, polymers, etc.), 2–50 μm in size. The components of
the sample mixture are separated from each other due to their different degrees of interaction with the
adsorbent particles. The pressurized liquid is typically a mixture of solvents (e.g., water, acetonitrile and/or
methanol) and is referred to as a "mobile phase". Its composition and temperature play a major role in the
separation process by influencing the interactions taking place between sample components and
adsorbent. These interactions are physical in nature, such as hydrophobic (dispersive), dipole–dipole and
ionic, most often a combination.
• HPLC, typical column dimensions are 2.1–4.6 mm diameter, and 30–250 mm length. Also HPLC columns
are made with smaller adsorbent particles (2–50 μm in average particle size)

18. CONCLUSION
• Industrial training is very much essential for pharmacy student. It is also a great
opportunity to acquire practical knowledge. During my training period, in the
industry I acquired lot of experiences in Quality control. This will help me to clarify
my theory knowledge. I hope and pray that it will help me much in my future
profession.
• During our training period, we had seen the various instrument and apparatus in
the industry, The highly sophisticated instrument the work precisely must be
operated with intense care for optimum use. We could acquire a lot of
information regarding the latest instrument and their working procedure.
• Apart from all that, the training was very interesting with lot of things to be
learned. It helped us to acquire knowledge on punctuality, regularity and working
environment in industries.
• Hence we can say that our goal of attending the industrial tour is fulfilled. s